Events

Recall of CENTRICITY LABORATORY - INSTRUMENT INTERFACING/I:NET

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE).

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53731
  • Event Risk Class
    III
  • Event Initiated Date
    2010-10-07
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Under specific conditions the laboratory system may truncate a value on an instrument re-run (eg. a result of 1.025 would be truncated at 1. and reported as 1.000).

Device

CENTRICITY LABORATORY - INSTRUMENT INTERFACING/I:NET
  • Model / Serial
    Model Catalog: INSTRUMENT INTERFACING/INET (Lot serial: 4.1.0 OR HIGHER); Model Catalog: INSTRUMENT INTERFACING/INET (Lot serial: SOFTWARE VERSIONS 4.0.0.9 OR); Model Catalog: INSTRUMENT INTERFACING/INET (Lot serial: HIGHER & SOFTWARE VERSION)
  • Product Description
    CENTRICITY LABORATORY - INSTRUMENT INTERFACING
  • Manufacturer
    GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)

Manufacturer

GENERAL ELECTRIC CANADA (OPERATING AS GE HEALTHCARE)